Completed

ADAPAdalimumab (Humira) in the Treatment of Chronic Pouchitis

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What is being tested

Adalimumab

+ Placebo

Drug
Who is being recruted

Colitis+9

+ Colonic Diseases

+ Digestive System Diseases

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorOdense University Hospital
Last updated: January 28, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

This study wants to investigate the efficiency of biological treatment for chronic pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It is examined in patients with ulcerative colitis. The primary objective evaluation is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis. Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity. It is a double-blinded randomized placebo controlled study.

NCT01670240
Principal SponsorOdense University Hospital
Last updated: January 28, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

13 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColitisColonic DiseasesDigestive System DiseasesEnteritisGastroenteritisGastrointestinal DiseasesIleal DiseasesIleitisIntestinal DiseasesInflammatory Bowel DiseasesColitis, UlcerativePouchitis

Criteria

9 inclusion criteria required to participate
Age > 18 years
Diagnosed with chronic pouchitis as defined above
Negative examination for tuberculosis (including x-ray of thorax and a interferon gamma test)
Negative stool cultures for bacterial bowel pathogens and negative stool microscopy for parasites
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12 exclusion criteria prevent from participating
A diverting stoma
Abuse of medicine, alcohol or drugs
Contraindications against treatment with tumor necrosis factor-alpha antibody, such as heart disease, former cancer disease, in vivo vaccination within the last 4 weeks
Diagnosed with Crohn's disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Every second week, mg: 160-80-40-40-40-40 12 weeks in all

Group II

Placebo
Given as the active comparator, every second week

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Odense University Hospital

Odense, DenmarkOpen Odense University Hospital in Google Maps
CompletedOne Study Center